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Conservative management for AR safe at 10 years

Whether to operate on patients with severe aortic regurgitation (AR) before or after symptoms appear has been a point of controversy among cardiothoracic surgeons, but a recent study has found that patients who have early surgery may not fare any better for up to 10 years than those who opt for a more conservative “watchful waiting” course of care.

Investigators from Belgium reported results from an analysis of 160 patients in the November issue of the Journal of Thoracic and Cardiovascular Surgery (2015;150:1100-08). “In asymptomatic severe AR, delaying surgery until the onset of class I/IIa operative triggers is safe, supporting current guidelines,” said Dr. Christophe de Meester and colleagues at the Catholic University of Louvain and St. Luc University Clinic in Brussels.

The goal of the study was to evaluate long-term outcomes and incidence of cardiac complications in patients with severe AR who did not have any signs and symptoms that called for surgery, and who either had surgery early on or entered conservative management and eventually had an operation when signs and symptoms did appear.

The study found that close follow-up and monitoring of patients with severe AR was a cornerstone of successful conservative management. “We found that survival was similar between the two groups,” Dr. De Meester and coauthors said. “Better survival was nonetheless observed in conservatively managed patients with regular as opposed to no or a looser follow-up.”

The most recent European Society of Cardiology (ESC) guidelines and American Heart Association/American College of Cardiology guidelines state that symptomatic severe AR is a class I indication for surgery regardless of left ventricular (LV) systolic function.

However, Dr. De Meester and colleagues said, the timing of that surgery is not so clear-cut. Earlier studies have shown that surgery could be delayed for patients with minimal symptoms, but more recent evidence has suggested the opposite, according to the study. Two factors favor surgery before symptoms arise – poor aortic valve repair outcomes in patients with symptoms of heart failure and long-standing severe AR, which eventually leads to LV dysfunction.

Yet, the latest ESC guidelines have been “reluctant” to make a strong case for early surgery before symptoms of LV dysfunction appear, and the AHA/ACC guidelines call for surgery only when symptoms of LV dysfunction or LV dilatation develop, Dr. de Meester and his coauthors said.

In the past, the risks of aortic valve replacement were too high to consider early surgery, the study authors said. “However, with the advent of aortic valve repair, operative mortality and long-term outcomes have improved to such an extent that early surgery has become a plausible option for patients.”

But the risk of these patients developing symptoms for surgery was nonetheless low over 10 years, the study found: 7.4% for developing severe LV dilatation; 0.6% for becoming symptomatic; and 0.9% for developing LV dysfunction. Overall, the rate of adverse events in the study population was 9.9% at 10 years.

In the study, 69 patients were initially managed conservatively, 49 of whom were in the watchful waiting group that visited a cardiologist at least annually and another 20 considered an “irregular follow-up subgroup.” Among the watchful waiting group, 31 developed symptoms for surgery (only two declined surgery). Watchful waiting patients had five- and 10-year survival of 100% and 95%, respectively, compared with 90% and 79% among those who had irregular follow-up.

Overall, the conservatively managed group had outcomes better than or equal to the early surgery group. Ten-year cardiovascular survival was 96% in both groups, whereas event-free survival was 92% at 10 years in the conservatively managed group vs. 81% in the early surgery group.

The study was supported by the Belgium National Fund for Scientific Research. The authors had no conflicts to disclose.

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The design of the Belgium study “challenges” existing treatment guidelines for asymptomatic chronic aortic insufficiency in two ways, Dr. Leora Balsam and Dr. Abe deAndra Jr., both of the New York University-Langone Medical Center, write in their commentary (J Thorac Cardiovasc Surg. 2015;150:1108-10): first, by making aortic valve repair the preferred surgical treatment in the study and, secondly, by offering surgery to both symptomatic and asymptomatic patients.

“In the era of evidence-based medicine,” Dr. Balsam and Dr. deAndra wrote, “there remains a need for research and innovation even in areas where guidelines exist.”

While many authors have described aortic valve repair as an alternative to aortic valve replacement for chronic severe aortic insufficiency, Dr. Balsam and Dr. deAndra explained that the term aortic valve repair “encompasses a wide array of techniques,” among them valve-sparing aortic root replacement, subcommissural annuloplasty and “myriad” leaf resection, plication, and reconstruction techniques. Because of mounting reports of excellent results with aortic valve repair techniques, growing ranks of cardiothoracic surgeons have advocated for repair as an early intervention for aortic valve problems. But the question remains: “Have we identified the optimal triggers for intervention for aortic insufficiency?” they asked. “The answer is probably no, and that newer technology and diagnostic studies will better discriminate between patients that can benefit from intervention and those that will not.”

Dr. Balsam and Dr. deAndra had no disclosures.

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The design of the Belgium study “challenges” existing treatment guidelines for asymptomatic chronic aortic insufficiency in two ways, Dr. Leora Balsam and Dr. Abe deAndra Jr., both of the New York University-Langone Medical Center, write in their commentary (J Thorac Cardiovasc Surg. 2015;150:1108-10): first, by making aortic valve repair the preferred surgical treatment in the study and, secondly, by offering surgery to both symptomatic and asymptomatic patients.

“In the era of evidence-based medicine,” Dr. Balsam and Dr. deAndra wrote, “there remains a need for research and innovation even in areas where guidelines exist.”

While many authors have described aortic valve repair as an alternative to aortic valve replacement for chronic severe aortic insufficiency, Dr. Balsam and Dr. deAndra explained that the term aortic valve repair “encompasses a wide array of techniques,” among them valve-sparing aortic root replacement, subcommissural annuloplasty and “myriad” leaf resection, plication, and reconstruction techniques. Because of mounting reports of excellent results with aortic valve repair techniques, growing ranks of cardiothoracic surgeons have advocated for repair as an early intervention for aortic valve problems. But the question remains: “Have we identified the optimal triggers for intervention for aortic insufficiency?” they asked. “The answer is probably no, and that newer technology and diagnostic studies will better discriminate between patients that can benefit from intervention and those that will not.”

Dr. Balsam and Dr. deAndra had no disclosures.

Body

The design of the Belgium study “challenges” existing treatment guidelines for asymptomatic chronic aortic insufficiency in two ways, Dr. Leora Balsam and Dr. Abe deAndra Jr., both of the New York University-Langone Medical Center, write in their commentary (J Thorac Cardiovasc Surg. 2015;150:1108-10): first, by making aortic valve repair the preferred surgical treatment in the study and, secondly, by offering surgery to both symptomatic and asymptomatic patients.

“In the era of evidence-based medicine,” Dr. Balsam and Dr. deAndra wrote, “there remains a need for research and innovation even in areas where guidelines exist.”

While many authors have described aortic valve repair as an alternative to aortic valve replacement for chronic severe aortic insufficiency, Dr. Balsam and Dr. deAndra explained that the term aortic valve repair “encompasses a wide array of techniques,” among them valve-sparing aortic root replacement, subcommissural annuloplasty and “myriad” leaf resection, plication, and reconstruction techniques. Because of mounting reports of excellent results with aortic valve repair techniques, growing ranks of cardiothoracic surgeons have advocated for repair as an early intervention for aortic valve problems. But the question remains: “Have we identified the optimal triggers for intervention for aortic insufficiency?” they asked. “The answer is probably no, and that newer technology and diagnostic studies will better discriminate between patients that can benefit from intervention and those that will not.”

Dr. Balsam and Dr. deAndra had no disclosures.

Title
Studies needed to determine who benefits
Studies needed to determine who benefits

Whether to operate on patients with severe aortic regurgitation (AR) before or after symptoms appear has been a point of controversy among cardiothoracic surgeons, but a recent study has found that patients who have early surgery may not fare any better for up to 10 years than those who opt for a more conservative “watchful waiting” course of care.

Investigators from Belgium reported results from an analysis of 160 patients in the November issue of the Journal of Thoracic and Cardiovascular Surgery (2015;150:1100-08). “In asymptomatic severe AR, delaying surgery until the onset of class I/IIa operative triggers is safe, supporting current guidelines,” said Dr. Christophe de Meester and colleagues at the Catholic University of Louvain and St. Luc University Clinic in Brussels.

The goal of the study was to evaluate long-term outcomes and incidence of cardiac complications in patients with severe AR who did not have any signs and symptoms that called for surgery, and who either had surgery early on or entered conservative management and eventually had an operation when signs and symptoms did appear.

The study found that close follow-up and monitoring of patients with severe AR was a cornerstone of successful conservative management. “We found that survival was similar between the two groups,” Dr. De Meester and coauthors said. “Better survival was nonetheless observed in conservatively managed patients with regular as opposed to no or a looser follow-up.”

The most recent European Society of Cardiology (ESC) guidelines and American Heart Association/American College of Cardiology guidelines state that symptomatic severe AR is a class I indication for surgery regardless of left ventricular (LV) systolic function.

However, Dr. De Meester and colleagues said, the timing of that surgery is not so clear-cut. Earlier studies have shown that surgery could be delayed for patients with minimal symptoms, but more recent evidence has suggested the opposite, according to the study. Two factors favor surgery before symptoms arise – poor aortic valve repair outcomes in patients with symptoms of heart failure and long-standing severe AR, which eventually leads to LV dysfunction.

Yet, the latest ESC guidelines have been “reluctant” to make a strong case for early surgery before symptoms of LV dysfunction appear, and the AHA/ACC guidelines call for surgery only when symptoms of LV dysfunction or LV dilatation develop, Dr. de Meester and his coauthors said.

In the past, the risks of aortic valve replacement were too high to consider early surgery, the study authors said. “However, with the advent of aortic valve repair, operative mortality and long-term outcomes have improved to such an extent that early surgery has become a plausible option for patients.”

But the risk of these patients developing symptoms for surgery was nonetheless low over 10 years, the study found: 7.4% for developing severe LV dilatation; 0.6% for becoming symptomatic; and 0.9% for developing LV dysfunction. Overall, the rate of adverse events in the study population was 9.9% at 10 years.

In the study, 69 patients were initially managed conservatively, 49 of whom were in the watchful waiting group that visited a cardiologist at least annually and another 20 considered an “irregular follow-up subgroup.” Among the watchful waiting group, 31 developed symptoms for surgery (only two declined surgery). Watchful waiting patients had five- and 10-year survival of 100% and 95%, respectively, compared with 90% and 79% among those who had irregular follow-up.

Overall, the conservatively managed group had outcomes better than or equal to the early surgery group. Ten-year cardiovascular survival was 96% in both groups, whereas event-free survival was 92% at 10 years in the conservatively managed group vs. 81% in the early surgery group.

The study was supported by the Belgium National Fund for Scientific Research. The authors had no conflicts to disclose.

Whether to operate on patients with severe aortic regurgitation (AR) before or after symptoms appear has been a point of controversy among cardiothoracic surgeons, but a recent study has found that patients who have early surgery may not fare any better for up to 10 years than those who opt for a more conservative “watchful waiting” course of care.

Investigators from Belgium reported results from an analysis of 160 patients in the November issue of the Journal of Thoracic and Cardiovascular Surgery (2015;150:1100-08). “In asymptomatic severe AR, delaying surgery until the onset of class I/IIa operative triggers is safe, supporting current guidelines,” said Dr. Christophe de Meester and colleagues at the Catholic University of Louvain and St. Luc University Clinic in Brussels.

The goal of the study was to evaluate long-term outcomes and incidence of cardiac complications in patients with severe AR who did not have any signs and symptoms that called for surgery, and who either had surgery early on or entered conservative management and eventually had an operation when signs and symptoms did appear.

The study found that close follow-up and monitoring of patients with severe AR was a cornerstone of successful conservative management. “We found that survival was similar between the two groups,” Dr. De Meester and coauthors said. “Better survival was nonetheless observed in conservatively managed patients with regular as opposed to no or a looser follow-up.”

The most recent European Society of Cardiology (ESC) guidelines and American Heart Association/American College of Cardiology guidelines state that symptomatic severe AR is a class I indication for surgery regardless of left ventricular (LV) systolic function.

However, Dr. De Meester and colleagues said, the timing of that surgery is not so clear-cut. Earlier studies have shown that surgery could be delayed for patients with minimal symptoms, but more recent evidence has suggested the opposite, according to the study. Two factors favor surgery before symptoms arise – poor aortic valve repair outcomes in patients with symptoms of heart failure and long-standing severe AR, which eventually leads to LV dysfunction.

Yet, the latest ESC guidelines have been “reluctant” to make a strong case for early surgery before symptoms of LV dysfunction appear, and the AHA/ACC guidelines call for surgery only when symptoms of LV dysfunction or LV dilatation develop, Dr. de Meester and his coauthors said.

In the past, the risks of aortic valve replacement were too high to consider early surgery, the study authors said. “However, with the advent of aortic valve repair, operative mortality and long-term outcomes have improved to such an extent that early surgery has become a plausible option for patients.”

But the risk of these patients developing symptoms for surgery was nonetheless low over 10 years, the study found: 7.4% for developing severe LV dilatation; 0.6% for becoming symptomatic; and 0.9% for developing LV dysfunction. Overall, the rate of adverse events in the study population was 9.9% at 10 years.

In the study, 69 patients were initially managed conservatively, 49 of whom were in the watchful waiting group that visited a cardiologist at least annually and another 20 considered an “irregular follow-up subgroup.” Among the watchful waiting group, 31 developed symptoms for surgery (only two declined surgery). Watchful waiting patients had five- and 10-year survival of 100% and 95%, respectively, compared with 90% and 79% among those who had irregular follow-up.

Overall, the conservatively managed group had outcomes better than or equal to the early surgery group. Ten-year cardiovascular survival was 96% in both groups, whereas event-free survival was 92% at 10 years in the conservatively managed group vs. 81% in the early surgery group.

The study was supported by the Belgium National Fund for Scientific Research. The authors had no conflicts to disclose.

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Conservative management for AR safe at 10 years
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FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

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Key clinical point: Delaying surgery until the onset of symptoms of aortic insufficiency is safe, in support of current clinical guidelines.

Major finding: Ten-year cardiovascular survival was equal among conservatively managed and early-surgery groups, but event free survival was 92% at 10 years in the conservatively managed group vs. 81% in the early surgery group.

Data source: Analysis of 160 consecutive asymptomatic patients with severe aortic regurgitation who were assigned to either conservative management or early surgery and followed up for a median of 7.2 years.

Disclosures: The Belgium National Fund of Scientific Research supported the study. The authors had no disclosures.